The delicate art of drafting FDA reform

WASHINGTON - FDA reform and Prescription Drug User Fee Reauthorization legislation proposed last week by Senator James Jeffords (R-Vt.) reflects the involvement of government, industry, patients and scientists in the drafting process. The process, especially the negotiation between technical experts from the Biotechnology Industry Organization, PhRMA and FDA, first in private meetings over several months and later in the presence of Senate Labor and Human Resources Committee staff members, led to the resolution of several issues that had derailed reform efforts in the previous Congress.

Discussions with patients and their advocates led to the inclusion of measures

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